Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC)
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|ClinicalTrials.gov Identifier: NCT04831450|
Recruitment Status : Not yet recruiting
First Posted : April 5, 2021
Last Update Posted : September 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma HNSCC Squamous Cell Carcinoma of the Larynx Squamous Cell Carcinoma of the Oral Cavity Squamous Cell Carcinoma of Hypopharynx||Drug: Cemiplimab-Rwlc||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Maintenance Cemiplimab-rwlc After Concurrent Chemoradiotherapy (CRT) in Intermediate and High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC)|
|Estimated Study Start Date :||November 1, 2021|
|Estimated Primary Completion Date :||June 1, 2025|
|Estimated Study Completion Date :||June 1, 2025|
Experimental: Cemiplimab After CRT in HNSCC
Participants will receive Cemiplimab for 6 consecutive months (a total of 8 cycles) 14-42 days after completion of standard of care CRT.
350 mg Cemiplimab administered via intravenous infusion over 30 minutes on Day 1 of a 21-day cycle.
Other Name: REGN2810
- Progression-Free Survival (PFS) [ Time Frame: Up to 2 years ]Progression-Free Survival (PFS) is defined as the elapsed time from the date of starting maintenance treatment until disease progression or death (whichever occurs first). Patients who have not had an event will be censored at the date of last disease assessment documenting the patient was free of progression. Progression will be assessed using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
- PFS Rate [ Time Frame: Up to 1 year ]PFS is defined as the elapsed time from the date of starting maintenance treatment until disease progression or death (whichever occurs first). Patients who have not had an event will be censored at the date of last disease assessment documenting the patient was free of progression. Progression will be assessed using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
- Overall Survival (OS) [ Time Frame: Up to 2 years ]Overall survival (OS) will be defined as the elapsed time from the date of starting maintenance treatment (Cycle 1 Day 1) until death. Alive patients will be censored at the date of last known to be alive.
- Incidence of Treatment-Related Toxicity and Adverse Events [ Time Frame: Up to 9 months ]Safety of the intervention will be reported as the incidence of treatment-related toxicity, including serious adverse events (SAEs) and adverse events (AEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04831450
|Contact: Jacqueline Rodriguez Amado||305-243-5620||jxr@firstname.lastname@example.org|
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Contact: Jacqueline Rodriguez Amado 305-243-5620 jxr@email@example.com|
|Principal Investigator: Chukwuemeka Ikpeazu, MD|
|Principal Investigator:||Chukwuemeka Ikpeazu, MD||University of Miami|